Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05403736

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine adherence to cardio-oncology consultation.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: Cardiac Aggressive Risk MitigAtion Plan	N/A

Detailed Description

The purpose of this study is to evaluate patient participation in a plan to improve heart health after radiation therapy by having a cardio-oncology assessment early during cancer treatment. Cardiologists and cancer doctors will review any cardiovascular risk factors (heart conditions, hypertension, bleeding disorders, smoking history, obesity, cholesterol and diabetes) and develop a personalized treatment plan. In addition, the study will evaluate use of wearable devices such as a FitBit, and remote EKG (Omron EVOLV) and blood pressure monitoring (AliveCor KardiaMobile) devices to monitor participant's health. Blood will be drawn at three separate timepoints for biomarker testing of heart injury, aging, inflammation and metabolism.

Study visits will occur at baseline, weekly during radiation therapy, 6 weeks and 3 months after completion of radiation therapy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open LabelOpen Label

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

IIT2021-07-Atkins-CARMA: Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CARMA Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring	Other: Cardiac Aggressive Risk MitigAtion Plan Cardio-oncology consultation along with long-term collaborative cancer care visits during standard of care radiation therapy that will occur weekly for up to 6 weeks followed by 6-week and 3-month follow-up visits. Health will be monitored with biosensor monitoring devices. Other Names: FitBit Omron EVOLV Automatic Blood Pressure Monitor AliveCor KardiaMobile Personal EKG Monitor cardio-oncology consultation

Arm

Intervention/Treatment

Experimental: CARMA

Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring

Other: Cardiac Aggressive Risk MitigAtion Plan

Cardio-oncology consultation along with long-term collaborative cancer care visits during standard of care radiation therapy that will occur weekly for up to 6 weeks followed by 6-week and 3-month follow-up visits. Health will be monitored with biosensor monitoring devices.

Other Names:

FitBit

Omron EVOLV Automatic Blood Pressure Monitor

AliveCor KardiaMobile Personal EKG Monitor

cardio-oncology consultation

Outcome Measures

Primary Outcome Measures

Number of participants who complete the cardio-oncology consultation visit [From baseline to 3 months]
Adherence is defined as 70% of the participants completing the cardio-oncology consultation visit prior to or during radiotherapy.

Secondary Outcome Measures

Number of participants who wear the FitBit device at least 10 hours per day for 4 out of the 7 days prior to each study visit [From baseline to 3 months]
Proportion of participants who wear the FitBit device at least 10 hours per day for 4 out of the 7 days prior to each study visit
Number of participants who obtain blood pressure readings for at least 4 timepoints [From baseline to 3 months]
Proportion of participants who obtain blood pressure readings for at least 4 timepoints. -The Omron blood pressure monitor will be used to obtain blood pressure readings.
Number of participants who obtain electrocardiogram (EKG) readings for at least 4 timepoints [From baseline to 3 months]
Proportion of participants who obtain EKG readings for at least 4 timepoints. -The AliveCor KardiaMobile EKG monitor will be used to obtain EKG readings
Rate of cardiovascular therapeutic medication intervention recommendations by the cardio-oncologist [From baseline to 3 months]
Number of participants provided recommendation to either initiate, or modify the dose of, a cardiovascular risk-reducing medication (anti-lipid, anti-platelet, anti-coagulation, anti-hypertensive). Expressed as the number of participants as a fraction of the total number of participants.
Rate of compliance with cardiovascular therapeutic medication intervention [From baseline to 3 months]
Compliance will be assessed by self-reporting of medication usage at the 3-month follow-up and defined as yes or no for all recommended cardiovascular therapeutic medication interventions. Expressed as the number of participants as a fraction of the total number of participants.
Evaluate participant intervention perspectives at the end of the study. [At 3 months]
Analyze participate attitudes and perspectives on implementation and impact of the cardiovascular intervention plan. Participants will be asked to complete a survey at the 3-month visit. Each question is either answered on a scale of 1-4 or strongly agree-strongly disagree, where higher scores indicate the highest level of burden or disagreement, respectively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any stage (I-IV) malignancy being treated with high dose (≥30 Gy) radiotherapy where the heart is in the treatment field.
Have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
Planning to receive standard of care radiotherapy treatments.
Access to a smart device that has the capability to sync to the devices.
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Ability to read, write and understand English.